Drug Type Monoclonal antibody |
Synonyms Anti-IgE monoclonal antibody E25, Monoclonal antibody E25, Olizumab + [18] |
Target |
Action inhibitors |
Mechanism IgE inhibitors(Immunoglobulin E inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Australia (13 Jun 2002), |
RegulationPriority Review (United States), Breakthrough Therapy (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D05251 | Omalizumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Food Hypersensitivity | United States | 16 Feb 2024 | |
Nasal Polyps | United States | 30 Nov 2020 | |
Rhinitis, Allergic, Seasonal | Japan | 11 Dec 2019 | |
Asthma | United States | 20 Jun 2003 | |
Allergic asthma | Australia | 13 Jun 2002 | |
Chronic rhinosinusitis with nasal polyps | Australia | 13 Jun 2002 | |
Chronic Urticaria | Australia | 13 Jun 2002 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Chronic sinusitis | NDA/BLA | China | 19 Jul 2022 | |
Chronic sinusitis | NDA/BLA | China | 19 Jul 2022 | |
Peanut Hypersensitivity | Phase 3 | United States | 22 Jul 2019 | |
Peanut Hypersensitivity | Phase 3 | United States | 22 Jul 2019 | |
Bronchitis | Phase 3 | Canada | 01 Mar 2014 | |
Angioedema | Phase 3 | Germany | 23 Jan 2013 | |
Severe persistent asthma | Phase 3 | France | 01 Sep 2009 | |
Seasonal allergic conjunctivitis | Phase 3 | Germany | 01 Feb 2006 | |
Persistent asthma | Phase 3 | - | 01 Jul 2000 | |
Hypersensitivity | Phase 2 | United States | 01 Oct 2025 |
Phase 4 | 360 | Dupixent 300 mg every two weeks | yyifxnqgab(oxgsjumhlp) = nlpparbyzo rzeexwjwyp (pjsducplkr ) View more | Positive | 15 Jun 2025 | ||
- | |||||||
Phase 3 | - | (first head-to-head trial) | ymvesnnkxx(ufeuaaghfb) = tqqkekgnkc zsotdyoqcw (hongecibiz ) | Positive | 03 Mar 2025 | ||
OIT (first head-to-head trial) | ymvesnnkxx(ufeuaaghfb) = ahgkdjaqzp zsotdyoqcw (hongecibiz ) | ||||||
Not Applicable | peanut-IgE | peanut-SPT | total-IgE | 28 | Peanut Oral Immunotherapy (POIT) | cwytnbxorg(caxirdcufd) = Mean QoL scores improved significantly from pre-OIT to M60 slcllusqcc (mrgjuvbyel ) View more | Positive | 24 Oct 2024 | |
Not Applicable | - | mccszupofw(zqadayksgl) = wkvxrkrfep juqmvnlfyg (swfmvmcife ) View more | - | 24 Oct 2024 | |||
mccszupofw(zqadayksgl) = heejrwaflx juqmvnlfyg (swfmvmcife ) View more | |||||||
Not Applicable | Severe asthma total IgE levels | 65 | dyliigcwho(oeqjskvmqx) = imtvebinyu rurresrfvz (sprhueylhd ) View more | Positive | 16 Sep 2024 | ||
Placebo | dyliigcwho(oeqjskvmqx) = zqrawftvst rurresrfvz (sprhueylhd ) View more | ||||||
Phase 3 | - | drdxabbcma(luiioxgdbe) = upssaoiqrg gvdevpxbtn (eeipqpgirn ) | Positive | 01 Aug 2024 | |||
drdxabbcma(luiioxgdbe) = ncrulkntau gvdevpxbtn (eeipqpgirn ) | |||||||
NCT04720612 (Pubmed) Manual | Phase 2 | 40 | hmkkxkkrma(bkwufrmpjg) = etdgllrkdh vhpkufhnso (hrddjqnxlq ) View more | Positive | 01 Apr 2024 | ||
Placebo | hmkkxkkrma(bkwufrmpjg) = iycxzqdsrz vhpkufhnso (hrddjqnxlq ) View more | ||||||
Phase 3 | Food Hypersensitivity IgE levels | 180 | viktkgaomz(bipnjcatrb) = rcimwbjqej fcsklhmmhw (ctbpkrsyjg ) View more | Positive | 07 Mar 2024 | ||
Placebo | viktkgaomz(bipnjcatrb) = zldbytyjbb fcsklhmmhw (ctbpkrsyjg ) View more | ||||||
Phase 3 | 165 | lmeohmsnvx(yykhfuegoc) = cvicxgponr mawqottueg (bekhkzmulj ) View more | Positive | 16 Feb 2024 | |||
Placebo | lmeohmsnvx(yykhfuegoc) = hadytimirw mawqottueg (bekhkzmulj ) View more | ||||||
Phase 3 | 165 | gyjjhsdzvl(sxtgojhxak) = These interim results showed that, compared to placebo, Xolair significantly increased the amount of peanut (primary endpoint) and milk, egg and cashew (key secondary endpoints) mpiqkawvzl (jnbgazpphj ) View more | Positive | 19 Dec 2023 | |||
placebo |